Agenus Inc.

Agenus Reports 72% of Patients with Locally Advanced dMMR Colon Cancer Had No Cancer Remaining at Surgery Following Six Weeks of BOT+BAL in Phase 2 NEOASIS Study at ESMO 2026

Agenus reported Phase 2 NEOASIS results at ESMO 2026 showing 83% major pathologic response and 72% pathologic complete response in locally advanced dMMR colon cancer after just six weeks of neoadjuvant BOT+BAL. All 18 patients proceeded to surgery, side effects were mostly mild and manageable, and all patients were alive at a median follow-up of 15 months, with 16 of 18 free of recurrence. NKI investigators are enrolling a dMMR rectal cancer organ-preservation cohort, and Agenus is advancing the short-course approach in MSS colon cancer, which represents about 85% of early-stage colon cancer cases. BOT and BAL remain investigational outside Armenia with no FDA approval to date.

•7d ago

Armenia Grants First Marketing Authorizations for Agenus’ BOT+BAL in Previously Treated MSS Metastatic Colorectal Cancer

Armenia's Ministry of Health granted the world's first marketing authorizations for Agenus' BOT+BAL combination in previously treated MSS metastatic colorectal cancer without active liver metastases. The approvals, effective October 2, 2026, are conditional and valid for one year, and Agenus will evaluate similar submissions in other Eurasian Economic Union countries. The approval is a first commercial milestone for the lead franchise but comes from a small non-US regulator; Agenus still lacks FDA approval, and near-term revenue from Armenia is likely modest.

•24d ago

Agenus Reports 48% Estimated Three-Year Survival With BOT+BAL in Recurrent Ovarian Cancer at IGCS 2026

Agenus reported three-year follow-up data from the ovarian cancer cohort of its Phase 1b C-800-01 trial at IGCS 2026, with estimated three-year overall survival of 48% in recurrent ovarian cancer patients treated with botensilimab plus balstilimab. The survival estimate held steady from two years to three years, a plateau pattern suggesting durable benefit in a heavily pretreated population with a median of four prior lines of therapy, including platinum-resistant patients at 47% three-year survival. Objective response rate was 23% (8/35) with median overall survival of 14.8 months, and no new safety signals were observed. BOT and BAL remain investigational and are not FDA-approved, so this is supportive evidence rather than a regulatory catalyst.

•29d ago

Agenus Announces Peer-Reviewed Publication Linking BOT+BAL’s Durable Survival in MSS Metastatic Colorectal Cancer to Its Distinct Immune-Priming Mechanism

Agenus announced the peer-reviewed publication of mature Phase 1b data in Clinical Cancer Research for botensilimab plus balstilimab in refractory MSS metastatic colorectal cancer. The treatment demonstrated a median overall survival of 21.2 months and a 33% three-year survival rate in 123 heavily pre-treated patients, significantly exceeding the historical standard of care. Biomarker analyses confirmed responses in immunologically "cold" tumors with low mutational burden and no PD-L1 expression, validating the Fc-enhanced mechanism of action. Safety data showed no new signals, and the findings support the planned Phase 3 ROBBIN trial in neoadjuvant settings.

•2mo ago

Agenus Announces Updated NEST Phase 2 Publication Reporting Deep Pathologic Responses and No Observed Recurrences with Neoadjuvant BOT+BAL in Resectable Colon Cancer

Agenus announced updated results from the Phase 2 NEST trial showing neoadjuvant BOT+BAL achieved 32% pathologic complete response with no observed recurrences in MSS/pMMR colon cancer. The data revealed 88% of evaluable patients cleared ctDNA before surgery, and median follow-up extended to 32.2 months without treatment delays or Grade 4 adverse events. These findings support the strategic pivot to the planned global Phase 3 ROBBIN trial in curative-intent settings.

•2mo ago

Agenus Reports Second Quarter 2026 Results and Advances Phase 3 ROBBIN Trial of BOT+BAL in Neoadjuvant MSS Colon Cancer

Agenus reported Q2 2026 revenue of $34.5 million, up from $25.7 million in the prior year, driven by $6.4 million in pre-commercial product revenue for BOT+BAL and $28.1 million in non-cash royalties. The company narrowed its net loss to $0.6 million compared to a $30 million loss in Q2 2025. The company closed an oversubscribed private placement in July, securing $85 million in gross proceeds with warrants for up to an additional $255 million. This financing is expected to support operations and the execution of the ROBBIN trial into 2027 and beyond if warrants are fully exercised. Agenus is prioritizing resources for the Phase 3 ROBBIN trial in neoadjuvant MSS colon cancer, with initiation and first patient dosing anticipated in Q1 2027. Consequently, the company discontinued funding for the BATTMAN trial in refractory metastatic colorectal cancer to focus on the ROBBIN program, which targets a U.S. market opportunity estimated at over $7 billion annually.

•2mo ago

Agenus Announces Three BOT+BAL Presentations Spanning Neoadjuvant and Late-Line Colorectal Cancer and Advanced Sarcomas at ESMO 2026

Agenus announced that three abstracts evaluating its botensilimab and balstilimab combination have been accepted for poster presentation at the ESMO 2026 Congress in Madrid. The presentations will feature data from investigator-sponsored trials covering neoadjuvant colorectal cancer, refractory metastatic colorectal cancer, and advanced sarcoma. To date, approximately 1,300 patients have been treated with botensilimab and/or balstilimab across phase 1 and phase 2 clinical trials.

•3mo ago

Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer

Agenus announced an oversubscribed private placement raising $85 million upfront at a premium to market, with potential gross proceeds of up to $340 million including warrants. The financing provides cash runway through year-end 2031, earmarked to fund the ROBBIN Phase 3 registrational trial of neoadjuvant BOT+BAL in MSS colon cancer. As part of a strategic pivot, Agenus will discontinue financial support for the metastatic BATTMAN Phase 3 study and expand its board to include two directors designated by lead investor Commodore Capital.

•3mo ago

Agenus Reports Landmark BOT+BAL Data Showing 33% Three-Year Overall Survival in Refractory MSS Metastatic Colorectal Cancer Without Active Liver Metastases at ESMO GI 2026

Agenus reported three-year follow-up data from its Phase 1b C-800-01 study, showing a 33% overall survival rate and 21.2-month median OS for the BOT+BAL combination in refractory MSS metastatic colorectal cancer. The results demonstrated a survival plateau beyond two years in a heavily pretreated population, with 17% of patients alive and off systemic therapy at last follow-up. Safety data indicated no new signals and 98% resolution of immune-mediated diarrhea/colitis, supporting the ongoing randomized Phase 3 BATTMAN trial.

•3mo ago

Agenus Presents Phase 2 BOT+BAL Melanoma Data Showing Durable Responses and Meaningful Survival in Advanced Checkpoint-Refractory Melanoma at ASCO 2026

Agenus presented Phase 2 data for its BOT+BAL combination in advanced melanoma patients refractory to prior checkpoint therapy. In the overall cohort of 36 heavily pretreated patients, median overall survival was 16.6 months, with 42% alive at two years and a 22% confirmed objective response rate. Responses were highly durable, with 86% of responders remaining in response at 12 months. In the dual-refractory subgroup, median survival was not reached and 64% were alive at two years. Safety was consistent with known checkpoint inhibitor profiles, with 36% experiencing grade 3+ treatment-related adverse events and no new safety signals.

•5mo ago

Agenus and Noetik Present ASCO 2026 Data Linking AI Analysis of Routine Pretreatment Tumor Pathology Images to Response and Survival with BOT+BAL in MSS Metastatic CRC

Agenus and partner Noetik presented retrospective data at ASCO 2026 showing that Noetik’s AI platform TARIO-2 can identify a subgroup of MSS metastatic colorectal cancer patients with a 64% response rate to Agenus’ BOT+BAL combination. This compares to a 9% response rate in the remaining cohort of 113 patients from the Phase 1b C-800-01 trial, with a hazard ratio of 0.18 for overall survival in the AI-identified group. The data supports the use of routine pathology images for patient stratification, potentially de-risking the ongoing Phase 3 BATTMAN trial by defining a responsive population for this next-generation immunotherapy.

•5mo ago

Agenus Announces Publication of Phase 1b Botensilimab and Balstilimab Data in Post-Immunotherapy Hepatocellular Carcinoma in Liver Cancer

Agenus published Phase 1b data for its botensilimab and balstilimab combination in patients with hepatocellular carcinoma who progressed after prior immunotherapy. The study of 19 heavily pretreated patients showed a 17% objective response rate and a median overall survival of 12.3 months, which compares favorably to historical controls in this difficult-to-treat population. The safety profile was manageable with no treatment-related deaths, supporting the continued development of the BOT+BAL regimen in late-line solid tumors.

•5mo ago

Agenus Reports First Quarter 2026 Financial Results and Highlights BOT+BAL Execution Across Global Access and Phase 3 Development

Agenus reported a strong financial turnaround in Q1 2026 with $33.7 million in revenue and net income of $39.2 million, driven largely by the Zydus collaboration which delivered $91 million in upfront capital and secured U.S. manufacturing capacity. Operationally, the lead program BOT+BAL advanced into Phase 3 enrollment with the BATTMAN trial, while the SEC investigation concluded without recommended enforcement action and related securities class action was dismissed. The company ended the quarter with $35.0 million in cash and raised an additional $11.7 million via an ATM offering post-quarter, targeting annualized operating expenses of approximately $50 million.

•5mo ago

Agenus to Present First Phase 2 Botensilimab Data in Advanced Cutaneous Melanoma at ASCO 2026

Agenus announced that four abstracts highlighting botensilimab alone or with balstilimab have been accepted for presentation at the ASCO 2026 Annual Meeting. The lineup includes the first Phase 2 clinical data presentation for advanced cutaneous melanoma, alongside trials-in-progress for colorectal cancer and translational biomarker research. Management highlighted strong momentum across the program, noting that approximately 1,200 patients have been treated with these agents to date.

•6mo ago

Agenus Names BAP Pharma as Exclusive Global Partner for BOT+BAL Access Programs

Agenus appointed BAP Pharma as its exclusive global partner to manage access programs for botensilimab and balstilimab, targeting authorized pathways like France’s AAC and paid named-patient programs. The partnership responds to significant demand, with Agenus citing over 270 physician inquiries from more than 30 countries seeking access to the therapies. This collaboration aims to streamline logistics and regulatory compliance for early access while Agenus continues its Phase 3 BATTMAN trial.

•6mo ago